AB0896 BEYOND CLINICAL TRIALS: EFFICACY AND SAFETY OF NINTEDANIB IN IPF AND PROGRESSIVE FIBROSING INTERSTITIAL LUNG DISEASES IN CLINICAL PRACTICE
Authors: A. I. De Gracia, C. Bea, E. Fuertes, A. De Castro, L. Navarro, C. Prades, D. Ruiz, P. Albiol, M. J. Forner, S. Vela-Bernal
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Since publication of clinical trials regarding the efficacy of nintedanib in fibrosing ILD, including the ILD associated with autoimmune diseases, its clinical use has increased but not enough real-world data has been published. <h3>Objectives</h3> The aim of our study was to evaluate the efficacy and safety of nintedanib in patients with interstitial lung diseases (ILDs) progressively fibrosing of several etiologies in a spanish third-level hospital. <h3>Methods</h3> A retrospective study was designed to collect clinical and radiological data of 31 patients under treatment with nintedanib, followed up by Internal Medicine, Rheumatology, or Pneumology specialists since 2016. <h3>Results</h3> Chacteristics of the study population are collected in Table 1. The indications for nintedanib were a fibrosis progression in the previous 24 months, determined as a decrease of Forced Vital Capacity higher than 10% in 25 patients (41,67%) or a decrease of 5-10% in 5 patients (8,33%). The increase of fibrosis in CT in 17 patients (28,33%) and a clinical worsening in 25 patients (41,67%) were also indications for treatment, as in pivotal trials. The mean time with nintedanib was 12,58 months (± 13,20). The drug was stopped in 9 patients (29%), 1 of them due to progression and 8 due to adverse effects, none of them severe, being the most frequent gastrointestinal. 12 patients died during follow-up. 7 (58,33%) were diagnosed with IFP, 4 with progressive fibrosis ILD, and 1 with ILD associated with systemic sclerosis. No significant differences between groups were found. Spirometric values were collected before treatment as well as at 3, 6, 12, and 24 months after starting treatment to compare the mean values of FVC (ml), FEV1 (ml), Tiffenau index and DLCO (%). The evolution of spirometric parameters is shown in graphic 1. No significant differences were found between them at baseline and after treatment, in accordance with the expected slowing of the progression to fibrosis. Regarding the evolution in radiological studies, fibrosis progression was only observed in a small percentage of patients. <h3>Conclusion</h3> Nintedanib was one of the first anti-fibrotic drugs with indication in fibrosis ILD. Not only for IPF but also for ILD of diverse aetiology, including those associated with autoimmune diseases, after the publication of clinical trials. Therefore, its use is increasing despite limited inclusion criteria in trials and scarce real-life clinical data. Our real-world study, even with its limitations, shows consistent results with those of the clinical trials, stabilising progression of pulmonary fibrosis in our population for the next 24 months after its start. <h3>References</h3> [1]Dister, O. Nintedanib for Systemic Sclerosis–Associated Interstitial Lung Disease. New England Journal of Medicine 380, no. 26 (2019) [2]Flaherty, K. Nintedanib in Progressive Fibrosing Interstitial Lung Diseases. New England Journal of Medicine 381, no. 18 (2019) <h3>Acknowledgements:</h3> NIL. <h3>Disclosure of Interests</h3> None Declared.